MAUDE manufacturer profile
ORTHO-CLINICAL DIAGNOSTICS, INC. · LOM
MAUDE profile for Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Key facts
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS, INC. |
|---|---|
| Manufacturer group | ORTHO-CLINICAL DIAGNOSTICS |
| Product code | LOM |
| Product code name | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) |
At a glance
- 100–999 MAUDE reports
- 1–9 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, False Positive Result, Incorrect, Inadequate or Imprecise Result or Readings, False Negative Result, Incorrect Or Inadequate Test Results, No Consequences Or Impact To Patient, High Test Results Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1